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GeoVax Labs, Inc. (OTC Bulletin Board: GOVX), an Atlanta-based, publicly traded biopharmaceutical company developing human vaccines for diseases caused by HIV-1 (Human Immunodeficiency Virus) and other infectious agents, announced the first injections in its Phase 2a Human Clinical Vaccine Trial for its candidate HIV/AIDS vaccine. The trial, designated HVTN 205, is being conducted by the HIV Vaccine Trials Network (HVTN). The HVTN, funded and supported by the National Institutes of Allergy and Infectious Diseases (NIAID), is the largest worldwide clinical trials network dedicated to the development and testing of HIV/AIDS vaccines. The HVTN has sponsored over 80 Phase 1 trials for the initial evaluation of safety and immunogenicity of candidate HIV/AIDS vaccines. The results of these trials have merited only five phase 2a trials since 1992. Progressing to Phase 2 is a significant step for GeoVax. The Company is pleased to report that the first injections for the Phase 2a trial were conducted at the HVTN network sites at the University of Alabama, Birmingham, and Vanderbilt University, Nashville.

The trial will include a total of 225 volunteers (150 vaccine recipients and 75 placebo recipients) and take place at 13 HVTN sites: 11 in North America and 2 in South America. Sites in the United States include Emory University, Atlanta; Harvard Medical School, Boston; Vanderbilt University, Nashville; University of Rochester; Fred Hutchinson Cancer Research Center, Seattle; the San Francisco Department of Public Health; University of Alabama, Birmingham and sites at Columbia University, Union Square, and the Bronx in New York City. In South America, participants are to be enrolled in Peru at sites in Iquitos and Miraflores (Lima).

"I am extremely pleased that our vaccine merited moving forward through the HVTN," said Harriet Robinson, Ph.D., developer of the vaccine and Senior V.P. of Research and Development at GeoVax. "This network provides a wide array of support for its clinical trials, from finances to statistical design and analysis; from community engagement to rigorous laboratory analysis. Working with the HVTN also affords us the input of the NIAID Prevention Science Research Committee, a committee with breadth of experience and knowledge in human vaccine development."

GeoVax's unique two component vaccine, a recombinant DNA and a recombinant modified vaccinia Ankara (MVA), is designed to stimulate both anti-HIV T cell and anti-HIV antibody immune responses. Stimulation of both T cells and antibodies differentiates the GeoVax vaccine from many other vaccine candidates. GeoVax's DNA and MVA vaccines are used in a prime-boost protocol in which priming is done with the DNA and boosting with the MVA. Both the DNA and MVA express the three major proteins of the AIDS virus: Gag, Pol, and Env, and produce non-infectious virus-like-particles. These particles contain proteins that mimic more than half of the components of the AIDS virus, but cannot cause AIDS. This multi-protein approach is designed to elicit a broad multi-target protective T cell response. The Env protein is designed to elicit a protective Ab response against the natural form of the virus envelope glycoprotein as well as protective T cells.

Dr. Paul Goepfert, principal Investigator of HVTN 205 and director of the University of Alabama trial site, said, "The road to an effective vaccine to prevent HIV infection is long and winding. It is vital to continue testing promising products. I am very pleased to aid in the further development of this important product in a phase 2 trial."

"For nearly 30 years since HIV/AIDS' discovery, researchers have been searching for a vaccine to combat its scourge," said Robert McNally, Ph.D., CEO and President of GeoVax Labs Inc. "Our Phase 1 trials found GeoVax's vaccines to be safe and immunogenic in humans. Good results from the Phase 2a human trial will build upon this foundation of safety and immunogenicity to support a Phase 2b efficacy trial."

In addition to the preventative vaccine entering Phase 2a, GeoVax also is working towards initiating human clinical trials testing its vaccines as potential therapies for people who are already infected with HIV. The goal of the therapeutic vaccination is to reduce the need of infected people for anti- viral drugs. Initial therapeutic trials will vaccinate infected people who are already on drugs to test the safety and immunogenicity of the vaccine in infected people. Therapeutic trials of a simian immunodeficiency virus (SIV) prototype of the GeoVax HIV vaccine in SIV infected primate animal models have held high promise that the GeoVax vaccine will be able to contribute to the control of HIV-1 in infected humans.

About GeoVax Labs, Inc.

GeoVax Labs, Inc. is a biotechnology company, established to develop, manufacture, license and commercialize human vaccines for diseases caused by HIV-1 (Human Immunodeficiency Virus) and other infectious agents. GeoVax's AIDS vaccine technology is the subject of 20 issued or filed patent applications. GeoVax AIDS vaccines are designed for use in uninfected people to prevent Acquired Immunodeficiency Disease (AIDS), caused by the virus known as HIV-1, should the person ever become infected. GeoVax AIDS vaccines also may be effective as therapeutics, treatment of people already infected with AIDS virus.

GeoVax's core AIDS vaccine technologies were developed by Dr. Harriet Robinson, Senior V.P. of Research and Development, through a collaboration of colleagues at Emory University's Vaccine Center, the National Institutes of Health (NIH), The Centers for Disease Control and Prevention (CDC) and GeoVax.

GeoVax AIDS vaccines have moved forward in human clinical trials conducted by the HIV Vaccine Trials Network (HVTN) based in Seattle, Washington. The HVTN, funded through a cooperative agreement with the National Institutes of Health (NIH), is the largest worldwide clinical trials program dedicated to the development and testing of AIDS vaccines. Preclinical work enabling evaluation of GeoVax DNA and MVA vaccines was funded and supported by NIAID, which provided additional support to GeoVax AIDS vaccine development program with a $15 million IPCAVD grant awarded in late 2007.

Safe Harbor Statement: All statements in this news release, not statements of historical fact, are forward-looking statements. These statements are based on expectations and assumptions on the date of this press release and are subject to numerous risks and uncertainties which could cause actual results to differ materially from those described in the forward-looking statements. Risks and uncertainties include, but are not limited to, whether: GeoVax can develop and manufacture these vaccines with the desired characteristics in a timely manner, GeoVax's vaccines will be safe for human use, GeoVax's vaccines will effectively prevent AIDS in humans, vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete vaccine development, there is development of competitive products that may be more effective or easier to use than GeoVax's products, and other factors over which GeoVax has no control. GeoVax assumes no obligation to update these forward-looking statements, and does not intend to do so. Certain matters discussed in this news release are forward-looking statements involving certain risks and uncertainties including, without limitation, risks detailed in the Company's Securities and Exchange Commission filings and reports.

GeoVax Starts Injections For Phase 2a Human HIV/AIDS Vaccine Trial In USAIn addition to the preventative vaccine entering Phase 2a, GeoVax also is working towards initiating human clinical trials testing its vaccines as potential therapies for people who are already infected with HIV. The goal of the therapeutic vaccination is to reduce the need of infected people for anti- viral drugs. Initial therapeutic trials will vaccinate infected people who are already on drugs to test the safety and immunogenicity of the vaccine in infected people. Therapeutic trials of a simian immunodeficiency virus (SIV) prototype of the GeoVax HIV vaccine in SIV infected primate animal models have held high promise that the GeoVax vaccine will be able to contribute to the control of HIV-1 in infected humans.

Does anybody here had any idea that when will the therapeutic clinical trial take place? Sometimes I feel confused, therapeutic trial shall be much easy to get conclusion then preventive trial. (Viral load remain constant or lower, no ART further need for a period of time). Why don't GeoVax do the therapeutic clinical parallel with the preventive one? Is there any further concern?

I've been following Geovax for a while (also bought a little stock, so if it works i'll get cured and make a few $, lol). There has been very little info about therapeutic trials, and everything seems to be running about a year behind, but I'm thrilled they have finally started the phase II preventatives. I think part of the delay has been an attempt to improve delivery and production, which they are now partnering with a french company to help achieve. Not to mention funding.

The article below is the only recent one I've seen that mentions therapeutic trials to be started in 2009. Let's hope...

Dr. McNally presented a corporate overview of GeoVax and its DNA/MVA vaccine technology, showcasing the scientific rationale and encouraging data from the Company's completed studies and trials. Among the points discussed by Dr. McNally were:

* World class science and collaboration with leading institutions. Dr. McNally informed the audience of unique scientific collaboration between Emory University, the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC), which led to the formation of GeoVax and the exclusive license of technology developed at these institutions. * Large market opportunity. Dr. McNally presented information on the very attractive market opportunity available for a successful HIV/AIDS vaccine. GeoVax's unique vaccine with its potential use in both preventative and therapeutic applications holds promise for not only addressing an unmet medical need, but also for commercial success. * Intellectual property. Dr. McNally briefly reviewed GeoVax's patent portfolio, consisting of over 20 issued and pending patents covering the Company's vaccine technology and manufacturing methods. * Status of Phase 2a preventative clinical trial. Dr. McNally discussed the current status of the Company's Phase 2a preventative human vaccine trial. He noted that clinical sites had been activated and prospective subjects are being identified.* Planned therapeutic clinical trials. Dr. McNally briefly discussed the company's plans for moving into therapeutic human vaccine trials in 2009 - for treatment of people already infected with the HIV-1 virus. * Selection of DNA vaccine component. The Company has recently reviewed results from its preclinical studies; comparing the performance of its two DNA vaccine candidates - JS2 and JS7 - and has determined that the JS7 DNA vaccine (currently being distributed for the Company's Phase 2a trial) provides the best opportunity for success. Dr. McNally stated that the final selection of JS7 will accelerate the company's moving forward with the therapeutic clinical trials process. * Efficient MVA manufacturing process. Dr. McNally reviewed the Company's current process for making the MVA portion of its vaccine through chicken embryos, and discussed GeoVax's ongoing collaboration with Vivalis, S.A. to develop a duck embryonic stem cell platform which can support large scale bioreactor production to meet future commercial demand. * Governmental support. Dr. McNally noted that GeoVax is supported in two significant ways through the federal government. GeoVax's Phase 1 human clinical trials, as well as the current Phase 2a trial are conducted and paid for by the HIV Vaccine Trials Network (HVTN), which is funded by the National Institute of Allergy and Infectious Diseases (NIAID), a division of the NIH. GeoVax is also the direct recipient (in October 2007) of a 5-year, $15 million grant by the NIH in support of its HIV/AIDS vaccine development efforts. * Financial strength. In addition to the financial and resource support provided by HVTN and NIH, Dr. McNally also talked about the $10 million financing facility currently in place through a common stock purchase agreement with Fusion Capital. He noted that this facility provides the Company with financial security and flexibility to meet its short-term operational and clinical objectives, but that additional financing would be necessary to progress into the later stages of clinical development.

This is a very good news. I'm just scared of one thing... Of course a preventive vaccine would be huge ! and it would allowed us to have normal relationship with people which will be not scared of us anymore. But ! Imagine that a preventive vaccine is found before the therapeutic one... I'm scared that all the research on AIDS will go down and that they will not care of people infected (they will just wait that we die so that AIDS is removed from the planet .... )

Thanks for that link Cosmicdancer, it was very informative. For those who aren't going to read it all and want a summary of the therapeutic aspect (it underscores the importance of getting on treatment before there is too much damage to the immune system):

At the same time, based on highly promising preclinical results in infected non-human primates, GeoVax is working to test the ability of the vaccine to serve as a therapy for already infected people. This therapeutic application will vaccinate people who were placed on drugs within a year of infection to test if the vaccine response can supplant the need for continued drug treatment. If we are successful in this setting, GeoVax will test its therapeutic application in people with longer term infections to see if vaccination can supplant the need for drugs in persons who have undergone more immune system damage.

So, do I believe an HIV/AIDS vaccine is possible? The answer is a resounding “yes”. In the absence of a vaccine, the typical unvaccinated person who becomes HIV infected successfully controls the infection for about 10 years. What a vaccine needs to do is to tip this time of control to 40, 50, 60 years. The GeoVax vaccine, which elicits both protective Ab and protective T cells, can tip the time of control in non-human primates. I firmly believe the same will be true in humans.

Officials from the Chicago-based Ruth M. Rothstein CORE Center, "the largest outpatient infectious disease clinic in the Midwest " has decided against participating in an HIV vaccine trial being conducted by Atlanta-based GeoVax Labs, "citing concerns for patients and finances," the Chicago Free Press reports (Wooten, 8/6). According to MyFoxChicago.com, "The preliminary proposal, obtained exclusively by Fox Chicago, called for a small trial to take place at CORE later this year on Geovax's therapeutic vaccine, with possible future tests of the preventative vaccine there." Following the original proposal, the board of CORE Foundation -- "the public/private fundraising arm" of the CORE Center -- "terminated its agreement with Geovax to start discussions on vaccine trials." Cook County Board President Todd Stroger, who along with other government officials signed the original agreement for the trial to move forward, "suspects it's politics and not medicine that torpedoed Geovax at CORE," MyFoxChicago.com reports (Goldblatt, 8/5). "Regardless of the reasons, Stroger's camp said that they will continue to fight to hold the vaccine trials in Cook County," the Free Press reports (8/6).

Cook County Board President Todd Stroger, who along with other government officials signed the original agreement for the trial to move forward, "suspects it's politics and not medicine that torpedoed Geovax at CORE

I haven't been able to find any more info about this statement, other than smoothing-over platitudes released from Geovax. Anyone know anything else about this or what these 'politics' are or where they came from? I would hate to see this shot in the foot.

I haven't been able to find any more info about this statement, other than smoothing-over platitudes released from Geovax. Anyone know anything else about this or what these 'politics' are or where they came from? I would hate to see this shot in the foot.

I don't think the issues with CORE will affect progress on this, it sounds like a minor glitch. It looks like they will be giving an update when they present a company overview on September 10:

ATLANTA, Aug. 26 /PRNewswire-FirstCall/ -- GeoVax Labs, Inc. (OTCBulletinBoard: GOVX) (the "Company"), an Atlanta-based, biopharmaceutical company developing human vaccines for diseases caused by HIV-1 (Human Immunodeficiency Virus) and other infectious agents, today announced that Robert McNally, Ph.D., president and chief executive officer, will present a company overview at the Rodman & Renshaw 11th Annual Healthcare Conference on Thursday, September 10, 2009 at 4:30 p.m. ET at the New York Palace Hotel in New York.

To access the live webcast of the presentation, please visit the GeoVax website at http://www.geovax.com, or http://www.wsw.com/webcast/rrshq15/govx.ob. Please connect to the website at least 15 minutes prior to the presentation to allow for any necessary software downloads. An archived replay will be available on the Company's site for 90 days following the live presentation.

Dr. McNally will present an overview of GeoVax's vaccine technology and will report the latest progress on the Company's Phase 2a preventative human vaccine trial and plans for its upcoming therapeutic human vaccine trials. Management also plans to meet one-on-one with current and prospective GeoVax investors, analysts and other potential Company partners.

I haven't been able to get the video presentation to load on my browser for some reason, but there is a slide show on the site (same link as in Inching's post) that I presume is a summary of what they said. It doesn't appear to have any new info, except an assertion that therapeutic trials are set to begin first Q 2010 and that early results from the IIa preventative are promising - but no details on what that means. Anyone else get it to work and hopefully found out something new?

It's true that results from therapeutic trials should certainly be visible much earlier, but frankly Q1 2010 isn't that far off, so if they really do start then, we can't complain too much (although I'm sure we still will!).

I also think they are still being a little vague about expectations for the preventative trial since I don't think anyone seriously believes it will actually prevent infection, just suppress it when it does happen. But then again, when it comes to HIV vaccines, anything is possible. It would be good to have SOME kind of preliminary results since they supposedly started injecting around February, which is 8 months ago....

I agree with Dr. McNally statement: "(...) current costs for oral medications and thenumerous side effects of these drugs give further urgency to the need for atherapeutic vaccine (...)"

Protocol Submitted for Phase 1 Therapeutic HIV/AIDS Vaccine Trial

ATLANTA, Sept. 21 /PRNewswire-FirstCall/ -- GeoVax Labs, Inc. (OTC BulletinBoard: GOVX) (the "Company"), an Atlanta-based, biopharmaceutical companydeveloping human vaccines for diseases caused by HIV-1 (Human ImmunodeficiencyVirus) and other infectious agents, today announced that it has requested apre-Investigational New Drug (IND) meeting with the U.S. Food and DrugAdministration (FDA) to discuss a proposed IND for GeoVax's therapeuticvaccine as a treatment for individuals infected with HIV/AIDS.

HIV affects the entire globe and comes in a variety of subtypes. Clade B isthe predominant subtype in North America, where there are roughly 60,000 newinfections each year. Globally, there are about 2.5 million AIDS infectionsper year, most primarily involving subtypes AG, B, and C. In 2007, UNAIDSreported 1.3 million people living with AIDS in North America and 33.2 millionpeople living with AIDS worldwide.

"This pre-IND meeting with the FDA is a significant step toward meeting theneeds of those individuals currently infected with HIV/AIDS. The FDA has 60days from our submission to review our proposal and respond with questions orcomments," stated Robert McNally, Ph.D., president and chief executiveofficer. "The need for a HIV/AIDS vaccine is clear, based on the continuedincrease of new infections in the United States, despite years of educationand preventative measures. Current costs for oral medications and thenumerous side effects of these drugs give further urgency to the need for atherapeutic vaccine," noted Dr. McNally.

A new IND with the FDA is required since this will be the first time theGeoVax vaccine will be used for a therapeutic application. The Phase 1therapeutic protocol stresses safety parameters to minimize any risk to thevolunteers. The protocol, conceived with collaboration from ARCA (AIDSResearch Consortium of Atlanta), has specific objectives to optimize safetywhile evaluating the ability for the vaccine to elicit protective immuneresponses in vaccinated participants. The proposed trial is based on theachievement of excellent post vaccine viral control in animal trials conductedin recently infected non-human primates at the Yerkes National PrimateResearch Center, affiliated with Emory University. The proposed human trialfollows the precedents set in the preclinical animal trials and is a criticalstep towards developing a therapeutic vaccine for HIV-1 infected humans.

Submission of a request to the FDA for a pre-IND meeting is the first step ina process that is expected to take a number of months to complete. Commencement of the trial is targeted for the first quarter of 2010.

Glad to see Geovax going for the therapeutic trials, if nothing else at least this vaccine could be strong enough to give us all a break from meds. A preventative vaccins is a tough nut to break due to the immense viral build-up in the first 7-10 days of infection. Any immune response must be pretty powerful to mount a strong enough attack to stop the virus from establishing itself in the body. Think of the Flu vaccine ----- it takes 2 to 4 weeks for enough antibodies to be made to neutralise the flu. The flu is like a gentle breeze compared to the hurricane force of hiv in establishing itself in the body. Add to the aforementioned that HIV has the ability to hjde from the immune system, you have a formidable enemy.

3 years ago when I was infected --> I hope there is a cure.2 years ago when I took HARRT for 10 month--> I hope there is "functional cure"1 years ago when my face sunk --> I hope something that can stop me from taking the drug for 5 yearand this year, right now--> I hope there is something that can give me a 6 month break from drug....

Here is an update on the progress for the therapeutic trial. They're looking at starting early 2010 if all goes as planned:

FDA Grants GeoVax Labs, Inc. Request For Pre-IND Meeting

ATLANTA, Nov. 17 /PRNewswire-FirstCall/ -- GeoVax Labs, Inc. (OTC Bulletin Board: GOVX) (the "Company"), an Atlanta-based, biopharmaceutical company developing human vaccines for diseases caused by HIV-1 (Human Immunodeficiency Virus) and other infectious agents, today announced that the U.S. Food and Drug Administration (FDA) has granted its request for a pre-IND meeting to discuss the proposed Investigational New Drug (IND) application for GeoVax's therapeutic vaccine as a treatment for individuals already infected with HIV. The meeting will only take place if the Company is not satisfied or requires some clarification to the FDA's answers to the questions submitted in the pre-IND package. Following the FDA response to the Pre-IND meeting questions, GeoVax will prepare and submit to the FDA an IND application for the therapeutic trial.

Robert McNally, Ph.D., president and chief executive officer, stated, "In anticipation of a pre-IND meeting in mid December, we have submitted a pre-IND information packet to the FDA. This packet includes rationale and supporting data for each question in the pre-IND package to allow a response from the FDA. The main purpose of the Pre-IND meeting is to ensure the FDA understands the purpose, approach and endpoints for the anticipated Phase 1 therapeutic trial and that we have answers to all of our questions to the FDA prior to filing the actual IND.

A new IND with the FDA is required since this will be the first time the GeoVax vaccine will be used for a therapeutic application. The Phase 1 therapeutic protocol stresses safety parameters to minimize any risk to the volunteers. The protocol, conceived with collaboration from ARCA (AIDS Research Consortium of Atlanta), has specific objectives to optimize safety while evaluating the ability for the vaccine to elicit protective immune responses in vaccinated participants. The proposed trial is based on the achievement of excellent post-vaccine viral control in animal trials conducted in recently infected non-human primates at the Yerkes National Primate Research Center, affiliated with Emory University. The proposed human trial follows the precedents set in the preclinical animal trials and is a critical step towards developing a therapeutic vaccine for HIV-1 infected humans.

The IND process is expected to take a number of months to complete. Based on the Company's current progress, commencement of the trial is targeted for early 2010.

I was reading that an effective preventive vaccine should also work in persons already infected, decreasing virus replication or stopping it definetely. If this is correct why Geovax is beginning trials for a therapeutic vaccine?

« Last Edit: November 24, 2009, 01:12:08 PM by xman »

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I was reading that an effective preventive vaccine should also work in persons already infected, decreasing virus replication or stopping it definetely. If this is correct why Geovax is beginning trials for a therapeutic vaccine?

Yes, it is possible that an effective preventive vaccine could possibly work as a therapeutic but it is not definite, there are many variables involved.

One of the surprises of the Thai vaccine was that it had no effect at all on the viral load or CD4 count of those people who did get HIV, something that really surprised researchers.

xman is correct. I believe the difficulty in getting to both a preventative and therapeutic vaccine is attaching to the non-mutatable targets on the virus (among other things) due to their location on the virus. I believe we discussed this on another thread.

xman is correct. I believe the difficulty in getting to both a preventative and therapeutic vaccine is attaching to the non-mutatable targets on the virus (among other things) due to their location on the virus. I believe we discussed this on another thread.

He was wondering what the point was of Geovax testing this vaccine for therapeutic purposes.

The only way they can know if the vaccine will work therapeutically is to test it.

In brief, they are beginning Phase 2A enrollment at the final site (in Peru) for their preventative vaccine. The next step is to submit an Investigational New Drug (IND) application for a therapeutic trial of the vaccine to the FDA. If the FDA does not express any concerns within 30 days after the application is filed, they can proceed. Only 5 vaccine candidates have gotten to a Phase 2 trial.

The preventative vaccine enrollment criteria is fairly limited. The trial will be conducted in Atlanta, and enrollment will be limited to people who started on ARVs within 6 months of testing positive.

Also, there's another press release on their site stating they will be presenting an update at an investors' conference tomorrow at 1 pm. It will be broadcast live on their website.

The preventative vaccine enrollment criteria is fairly limited. The trial will be conducted in Atlanta, and enrollment will be limited to people who started on ARVs within 6 months of testing positive.

I guess you meant to say "therapeutic."

I'm curious what the specific results were for the therapeutic vaccine they tried on non-human primates. Harriet Robinson has been quoted as saying, “Based on the success of the simian prototype of the GeoVax vaccine in controlling established infections in the non-human primate model, we believe our vaccine should be effective in at least some infected humans,”

Were the monkeys able to control their infection without any meds at all because of the vaccine? And if so, for how long?

I just don't get it, though. These monkeys had recently been exposed to the virus when they were vaccinated so the fact that they controlled the infection for over one year doesn't sound that impressive. It's well-known that, at least in humans, most people can control HIV for not just one year but for many years before it starts to really take over. In fact, that's the usual progression of HIV, most people can control it for at least a few years.

I do hope it works but a more realistic simian model would be if they took monkeys who had been living with the virus for several years and then vaccinated them.

"n this trial, two monkeys were infected with the SIV AIDS virus and then placed on drug therapy. Thereafter, once early drug therapy had temporarily reduced virus levels, the monkeys were vaccinated with the SIV version of GeoVax's DNA/MVA vaccines. Six weeks after vaccination, drug treatment was discontinued. The SIV virus levels temporarily rose in the vaccinated individuals, but were later "controlled" (reduced to much lower levels) by immune responses raised by the vaccines."

The viral load had to be high before drug therapy which suggests the monkeys were given the virus earlier since the drug therapy lowered the viral load.

"n this trial, two monkeys were infected with the SIV AIDS virus and then placed on drug therapy. Thereafter, once early drug therapy had temporarily reduced virus levels, the monkeys were vaccinated with the SIV version of GeoVax's DNA/MVA vaccines. Six weeks after vaccination, drug treatment was discontinued. The SIV virus levels temporarily rose in the vaccinated individuals, but were later "controlled" (reduced to much lower levels) by immune responses raised by the vaccines."

The viral load had to be high before drug therapy which suggests the monkeys were given the virus earlier since the drug therapy lowered the viral load.

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That's my point, soon after HIV exposure viral load goes way up and CD4s go down before things begin to stabilize. This is what happens in most cases of HIV infection without any intervention.

It's vague the way they describe it as far as how long the monkeys had been infected before they were vaccinated but it seems that the vaccination happened shortly after infection. In fact I think the whole point of this study is to vaccinate people within 6 months of infection, right?

As I said, I do hope it works but I have more faith in other approaches, such as stem cell therapy and even nanoviricides.

Inchingblue, the slide that John posted shows that the monkeys were put on ARVs 12 weeks after infection, and then after they had the virus well controlled, they began the first of 3 vaccinations at 50 weeks, the 2nd one at 58 weeks, and then the final one at 66 weeks. At week 72, treatement with ARVs was stopped. Viral loads increased briefly but then dropped significantly. 40 weeks later (at week 112), both monkeys still had viral loads significantly lower than the set points they were at at week 12. One was 100 times lower and the other was 1,000 times lower. According to the chart, it appears that the one monkey was undetectable at week 112.

The one thing I'd like to know is, given that this was in 2007, what's the condition of these monkeys now, over 2 1/2 years later. Are they still maintaining very low viral loads? Are there signs of disease progression or do they appear healthy? If their viral load climbs, would they benefit from booster shots every few years?

Also, we know that hiv does most of it's damage within the first 7 to 10 days of infection, establishing itself in the reservoirs in humans. Does this mechanism occur at the same rate in simians ? If the infection works more quickly in the monkeys, then the vaccination moa would be more relevant to the way humans get infected. Does anyone have any ideas?

Geovax has another vaccine in clinical trials. They reported at CROI that a "prototype adjuvant-supplemented HIV vaccine" was tested in preclinical animal studies, and results from the study using non-human primates indicate 70% level of protection from infection. 5 of the 7 primates were not infected despite repeated exposure to SIV. More details in the link below.

Geovax has another vaccine in clinical trials. They reported at CROI that a "prototype adjuvant-supplemented HIV vaccine" was tested in preclinical animal studies, and results from the study using non-human primates indicate 70% level of protection from infection.

Just to clarify, my understanding is that what they are talking about here is an adjuvant to the preventative vaccine currently in phase II trials (and when are the ever going to give us some data on that??). It's interesting because they went to all the trouble to get the current one into trials and now are saying that in case it doesn't work, the adjuvant might just do the trick. I'm glad I didn't have to write that press release. Now, if they would finally stop TALKING about testing theraputically and actually do it.

GeoVax Labs, Inc. (OTC Bulletin Board: GOVX), a biotechnology company that creates, develops, and tests innovative HIV/AIDS vaccines, is now allowed by the FDA (US Food and Drug Administration) to begin a phase 1 clinical trial for GeoVax's therapeutic vaccine, which is intended as a treatment for individuals infected with HIV (Human Immunodeficiency Virus). The company will begin a non-blinded study in HIV infected individuals who started drug treatment during their first year of infection.

Robert McNally, Ph.D., President and CEO of GeoVax, stated, "Based upon preclinical animal data, we believe our therapeutic vaccine may improve treatment options for people infected with HIV and are delighted we will be able to begin a phase 1 clinical trial. An unmet need exists in the market for a HIV therapeutic vaccine if it can reduce the need for expensive and poorly tolerated lifelong oral medications currently available to infected individuals. We also recognize that this trial will enable GeoVax to gather crucial information toward our vaccine's success on a more timely basis than the time required to perform a preventative trial."

The protocol for the Phase 1 clinical trial, conceived in collaboration with ARCA (AIDS Research Consortium of Atlanta), will carefully monitor safety while evaluating the ability of the vaccine to elicit protective immune responses in vaccinated participants. The next step of starting the process will be a submission by ARCA to the IRB (Institutional Review Board) for local review of trial documentation, a standard requirement to protect human subjects. The trial is based on the achievement of post-vaccine viral control in animal studies conducted in recently infected non-human primates at the Yerkes National Primate Research Center, affiliated with Emory University.

Study to Enroll HIV-Infected Individuals Who Started Drug Treatment During Their First Year of Infection

ATLANTA, May 27 /PRNewswire-FirstCall/ -- GeoVax Labs, Inc. (OTC Bulletin Board: GOVX), a biotechnology company that creates, develops and tests innovative HIV/AIDS vaccines, announced today The AIDS Research Consortium of Atlanta (ARCA) has received approval to begin enrollment of the first therapeutic trial ever conducted using a promising HIV vaccine candidate from GeoVax, Inc. Although the GeoVax vaccines are currently being studied for HIV prevention, this is the first study using the same products for treatment of persons who already have HIV infection. ARCA is the only site for this trial.

"ARCA is pleased to be conducting this important clinical trial," said Dr. Melanie Thompson, Principal Investigator for ARCA. "New approaches to HIV treatment are critically needed, and an effective therapeutic vaccine would be an important tool in our ongoing efforts to treat people with HIV infection. A vaccine that enhanced the body's ability to control HIV and delayed or decreased the dependence on anti-HIV drugs would be a major breakthrough for HIV treatment."

To be eligible for the study, persons should have had a negative HIV test followed by a positive test up to 6 months later, and they should have started drugs to fight HIV within 6 months of being diagnosed. The study will last up to 77 weeks. All patients will be followed closely for safety and for the ability of the vaccine to elicit protective immune responses in vaccinated participants. Patients will be compensated for their participation in the study. Only 10 to 12 persons will be selected to participate. Persons who believe they may qualify for the study should contact ARCA at vaccine@arcatlanta.org or 404-876-2317. ARCA is also interested in identifying possible candidates who fit the enrollment criteria but have not yet started anti-HIV drugs.

ARCA worked together with GeoVax to design the protocol for the Phase 1 clinical trial. The trial is based on the achievement of excellent post-vaccine viral control in animal studies conducted in recently infected non-human primates at the Yerkes National Primate Research Center, affiliated with Emory University.

This sounds very exciting, but is anyone interested in participating? I fit all of their criteria, but the fear of stopping HAART and risking resistance makes it difficult (if not impossible) for me to make that type of decision. Also, it sounds like all of the research is based on the result of testing with two monkeys. Is that enough preliminary testing?

This sounds very exciting, but is anyone interested in participating? I fit all of their criteria, but the fear of stopping HAART and risking resistance makes it difficult (if not impossible) for me to make that type of decision. Also, it sounds like all of the research is based on the result of testing with two monkeys. Is that enough preliminary testing?

If the trial is done correctly then any issues of resistance would be minimized if not completely eliminated.

Resistance to a drug only happens when the levels in one's system are too low to control the virus and/or if there are only one or two drugs present, as opposed to three (sometimes two drugs are enough to control HIV but not usually).

It's possible to go off meds without developing resistance if it's timed correctly based on the half lives of the medications in question.

If, for example, all three of the drugs in your combo have the same half life then stopping the medications all at once should not lead to resistance.

If the half lives vary, such as with Atripla, then to avoid resistance it's usually recommended to continue taking only Truvada for about a week to compensate for the fact that Sustiva (efavirenz) has a longer half life.

Thanks for the feedback, Inch...I enjoy reading your posts out here because you seem very informed.

I'm curious as to what you (or anyone) would personally use as a basis for making a decision to participate in such a trial (or would you)? I'm still very new to living with hiv but the thought that I could potentially take a shot (or series of shots) and not have to take meds anymore is exciting. As new as all of this is for me, I just feel that there are so many advances being made on so many fronts that it's possible that the end of HIV is in sight. Not having the years of experience that others out here have with this disease makes it difficult to determine if I am going through a "ridiculously hopeful/naive" phase or if all of the research news is as promising as it sounds.

That being said, "they" have been working for so long to find a cure that I'm not sure how one prepares himself to be a guinea pig. I know that sounds selfish as we would not have the meds that we have today if others hadn't been willing to take those risks, but that's how I feel.

Right now, I'm thinking that maybe I should just talk to my doctors about it and try to see if they could get involved to act as "agents". I did fire off an email to the company expressing an interest, but I'm not a doctor and have never played one on tv

"I'm curious as to what you (or anyone) would personally use as a basis for making a decision to participate in such a trial (or would you)? I'm still very new to living with hiv but the thought that I could potentially take a shot (or series of shots) and not have to take meds anymore is exciting. As new as all of this is for me, I just feel that there are so many advances being made on so many fronts that it's possible that the end of HIV is in sight. Not having the years of experience that others out here have with this disease makes it difficult to determine if I am going through a "ridiculously hopeful/naive" phase or if all of the research news is as promising as it sounds. "

I don't see the risk as very high. Say you stop HAART and take their vaccine. As Inch said - there is no issue with respect to resistance since doctors would make sure that the level of drugs in your body is kept uniform, so you are not subject to monotherapy (which is what causes resistance).

Then you would be monitored for the VL and CD4. Given that you are now UD and 795, I don't see much risk if the drug does not work. Your VL would rise and CD4 drop, but slowly and you would reinstate HAART at some point (that I imagine would be agreed upon before you commence) - probably way before the 500 count is reached.

On the upside - if you drug works you'll be able to enjoy its use years before all of us

actually resistance is when the level of med in your system reaches and sustains a low enough level that the virus is able to mutate against the med and withstand the effects of the med. Resistance can happen with monotherapy or HAART (although failure of HAART is usually user-failure of adherence).

monotherapy doesn't really cause resistance, as much as it just isn't able to disrupt enough of the HIV life cycle, therefore allowing HIV to continue to flourish. HAART, which is used today instead of monotherapy, is a combo of meds (entry inhibitors, reverse transcriptase inhibitors, intergrase inhibitors, protease inhibitors, and maturation inhibitors) that attack different portions of the HIV life cycle all at once. This multi-prong method attacks enough quantity of the HIV in your system, while at the same time inhibiting enough of the HIV actions thereby not giving the virus a chance to mutate. (http://www.aidsmeds.com/articles/hiv_life_cycle_5014.shtml)

of course, resistance could happen with monotherapy; but that's not the fault of monotherapy per se, as much as the problem with monotherapy is that it just doesn't do enough against HIV.

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leatherman (aka mIkIE)

All the stars are flashing high above the seaand the party is on fire around you and meWe're gonna burn this disco down before the morning comes- Pet Shop Boys chart from 1992-2015Isentress/Prezcobix

monotherapy doesn't really cause resistance, as much as it just isn't able to disrupt enough of the HIV life cycle, therefore allowing HIV to continue to flourish

Thanks for the layman's explanation, Leatherman. I didn't realize that was why there are three drugs in the Atripla that I take (the doctor probably told me and I didn't listen or "get it").

What are your thoughts about this vaccine trial? It doesn't sound to me like there will be any "drug" levels retained in the person's system as it is more focused on boosting an individual's immune system to battle HIV on its own. Is that right?

actually resistance is when the level of med in your system reaches and sustains a low enough level that the virus is able to mutate against the med and withstand the effects of the med. Resistance can happen with monotherapy or HAART (although failure of HAART is usually user-failure of adherence).

monotherapy doesn't really cause resistance, as much as it just isn't able to disrupt enough of the HIV life cycle, therefore allowing HIV to continue to flourish. HAART, which is used today instead of monotherapy, is a combo of meds (entry inhibitors, reverse transcriptase inhibitors, intergrase inhibitors, protease inhibitors, and maturation inhibitors) that attack different portions of the HIV life cycle all at once. This multi-prong method attacks enough quantity of the HIV in your system, while at the same time inhibiting enough of the HIV actions thereby not giving the virus a chance to mutate. (http://www.aidsmeds.com/articles/hiv_life_cycle_5014.shtml)

of course, resistance could happen with monotherapy; but that's not the fault of monotherapy per se, as much as the problem with monotherapy is that it just doesn't do enough against HIV.

Thanks for clarification. The way my doctor explained it to me - and this was in regard to stopping of medication completely (not missing doses) - is that certain part of the cocktail has a longer life inside your body. So if a patient stops taking Atripla, one drug will continue working for a few days longer than the other. That would give the virus a change to develop resistance to the drug that is no longer working.So for someone who plans to stop taking HAART, the doctors would provide separate a pill containing the drug that has shortest life inside the body, so that the patient can take it after stopping Atripla.

exactly. that would be the method to totally stopping HAART (but who would want to do that?), rather than switching over to a new regimen. A switch should cause no break in HAART treatment, and thus would not allow med levels to fall enough for any mutations to develop.

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leatherman (aka mIkIE)

All the stars are flashing high above the seaand the party is on fire around you and meWe're gonna burn this disco down before the morning comes- Pet Shop Boys chart from 1992-2015Isentress/Prezcobix

of course, resistance could happen with monotherapy; but that's not the fault of monotherapy per se, as much as the problem with monotherapy is that it just doesn't do enough against HIV.

Mikie, I find this sentence confusing. Monotherapy in the large majority of cases leads to resistance.

Boosted PI monotherapy can sometimes be enough to keep the virus at bay but it's not standard practice to prescribe this for most patients.

I guess what I don't get is saying it's "not the fault of monotherapy per se." When so many people acquired NRTI resistance due to AZT monotherapy in the early days of the epidemic it was in fact "the fault of monotherapy,'' in other words, it was directly and unequivocally due to monotherapy that the resistance occurred.

I guess what I don't get is saying it's "not the fault of monotherapy per se." When so many people acquired NRTI resistance due to AZT monotherapy in the early days of the epidemic it was in fact "the fault of monotherapy,'' in other words, it was directly and unequivocally due to monotherapy that the resistance occurred.

from my own anecdotal evidence, most of the people I know who were on AZT monotherapy, including myself, did not develop resistance to AZT; instead AZT was unable to adequately suppress the disease (ie did not adequately reduce the viral load). By only attacking HIV in one part of it's cycle, AZT did not affect enough HIV and HIV was able to continue replicating. It wasn't resistance to AZT, as much as AZT was unable to kill off enough of the rapidly reproducing HIV.

Of course, more than resistance issues, it was the toxic side effects that forced people off the monotherapy. Of course, as time went by, they found AZT was still an effective med, but at reduced levels - and when combined with other categories of HIV inhibitors.

http://www.thebody.com/content/treat/art2811.htmla large NIH-sponsored clinical trial which showed that AZT + ddI, AZT + ddC or ddI monotherapy were superior to AZT monotherapy in both AZT naive and experienced persons with CD4 counts between 200- and 500). Twenty seven patients (32%) had the codon 215 mutation which confers high level AZT resistance; these patients had a faster decline in CD4 cells and increasing HIV RNA viral load during 56 weeks of AZT monotherapy as compared to the 56 patients with wild-type virus. Of 42 patients with wild-type virus at entry, 31% developed codon 215 over the ensuing 56 weeks of follow-up. The concern about AZT resistance was magnified by the results of another study conducted in rural Iowa by Kozal and others who retrospectively sequenced the pol gene from HIV isolates of 99 patients presenting for evaluation from 1993-96. Although all were protease inhibitor naive, 29% had reverse transcriptase mutationsstudies like this one, showed only about 1/3 of patients developed resistance with AZT monotherapy.

http://hivinsite.ucsf.edu/InSite?page=ar-01-01Implications of zidovudine resistance for treatment with other antiretrovirals The addition of lamivudine or didanosine may maintain selective pressure for zidovudine-sensitive variants. In clinical trials, individuals treated with zidovudine monotherapy for many months experienced suppression of viral load lasting months to years following the addition of lamivudine and indinavir,(7) suggesting that resistance to zidovudine may take time to emerge or may be reversible with the addition of lamivudine. Interesting to see that AZT combined with Epivir might even reverse AZT resistance

http://www.annals.org/content/122/1/24.fullThe 12-month probabilities for severe or worse toxic effects were 45%... for the zidovudine, ...Neutropenia was the most common toxic side effect associated with zidovudine therapy,...with a higher incidence of severe or worse neutropenia in the zidovudine (41%) nearly half of monotherapy patients experienced severe white/red blood cell issues

for the time (late 80-early 90s), with what was known about HIV, and meds that were in trials/production, AZT was effective at keeping a great many people alive for a little longer until more meds could be developed and the need for a combination attack approach would be seen. However, many paid a price from the toxic side effects of the monotherapy.

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leatherman (aka mIkIE)

All the stars are flashing high above the seaand the party is on fire around you and meWe're gonna burn this disco down before the morning comes- Pet Shop Boys chart from 1992-2015Isentress/Prezcobix